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510(k) Data Aggregation
K Number
K131080Device Name
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE
Manufacturer
Date Cleared
2014-06-13
(445 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
REIMERS AND JANSSEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.
Device Description
Not Found
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K Number
K091675Device Name
LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
Manufacturer
Date Cleared
2009-12-15
(189 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
REIMERS AND JANSSEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthrilis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.
Device Description
RJ Low Level Laser Family
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